Regions

The members of the HIMSS EHR Association support the rules' goals – but say that as drafted they go beyond Congress' intent for 21st Century Cures, are too loosely defined, have too tight a timeline and require too much IP sharing.

The HIMSS Electronic Health Record Association has not yet formally submitted its comments on the proposed interoperability rules to the Office of National Coordinator for Health IT. But this week, the association posted on its blog that, while it supports the rules' goals for patient access, it has deep concerns that the "tremendously broad reach of the proposed rule goes far beyond Congressional intent."

WHY IT MATTERS
"In particular, we have significant concerns regarding timelines, ambiguous language, disincentives for innovation, and definitions related to information blocking," said HIMSS EHR Association officials in the post, which previews comments the group says are "going through final rounds of review" by its executive committee and seven workgroups and will be submitted soon to ONC.

Timeline challenges. The association says it polled its member companies – including Allscripts, Cerner, Epic, eClinicalWorks, Meditech and many others – to get a sense of the development resources that would be needed for vendors to comply with the voluminous proposed rules from ONC. The general consensus is that, "while some updated functionality or proposals may be straightforward to achieve in a short timeline, the proposed 24-month timeline for development, testing, training and implementation across all our clients is not feasible for the more challenging proposals, which require complex coding and implementation processes."

Language ambiguity. Certain sections of the proposed rulemaking "offer room for interpretation," the association notes, and words and phrases such as "reasonable" and "as soon as possible" could cause compliance challenges for vendors already grappling with an array of other federal regulations, officials said. For compliance with the ambiguous phrase "near real-time" could depend "on a number of factors which may be beyond the EHR developer’s control, such as capacity of a client’s hardware and the volume of data," they said. While considerations of those factors might be assumed, EHRA members are concerned that "our expectations may differ from the federal government’s."

Innovation concerns. EHRA said it's concerned that, "as written, the proposed rule would discourage innovation by imposing limitations on profit as well as compulsory licensing terms for new intellectual property, created through extensive investment in development." The blog post points out that, "essentially, it requires EHR developers and others to share their intellectual property with anyone who asks under 'Fair, Reasonable and Non-Discriminatory' terms. Normally, companies choose when and to whom they contribute their technology, such as through the standards development process, but a compulsory licensing model means that anyone could ask for our intellectual property, and for a 'reasonable' price-capped fee they’d be able to layer their own work over ours or otherwise repurpose it. Clearly this would have a chilling effect on innovation, by removing incentives for new or established companies to invest in emerging technologies or any significant effort to update existing ones."

What is information blocking? When it comes to its proposed rules prohibiting info blocking, EHRA's vendor members say ONC's definitions of terms such as “interoperability elements” and “electronic health information” are written far too broadly – to the point where they could conceivably affect “technologies and stakeholders well outside of what is reasonable," officials said. The group hopes the agency will revisit terms such as those and "significantly" narrow their definitions. It also notes that several components of ONC's proposed exceptions section "do not seem enforceable, either because of ambiguity, difficulty tracking, or the number of resources available" at ONC or the Office of Inspector General.

THE LARGER TREND
Since ONC this past month extended the comment period on its proposed rules to June 3, bowing to pressure from an an array of industry groups that they're "too important to not get right," many stakeholders have taken the extra time to fine-tune their lists of concerns.

Comments submitted so far, such as those from the American Medical Informatics Association reflect the unique perspectives of the groups whose constituents will have to abide by them. In AMIA's case, for instance, it focused on informatics concerns such as standardization and nomenclature, and called on ONC to encourage an ethos of "share now, standardize as needed" – helping break the a cycle of dependency where "patients, clinicians, and researchers are at the mercy of health IT developers to access their data routinely."

"I personally have probably had at least 200 stakeholder meetings in just under two years that I've been at ONC," he explained. "So we're doing this with a lot of input, from many different people. When you look at the scope of rules, it's important to understand that many of these are an outgrowth of American healthcare not really being in a market economy. We're trying to have proxies for the consumer, that if the consumer were in control and purchasing their care would happen automatically in a market economy."

ON THE RECORD
"Vague or ambiguous regulatory language can pose tremendous risk to affected stakeholders, especially where maximum penalties are as high as $1 million per infraction," said EHR Association officials. "Our comments will request that additional clarifications and examples be made before finalization of the rule, possibly through issuance of an Interim Final Rule rather than a Final Rule this fall, to allow continuation of the clarification and feedback process."

The association's vendor members "appreciate ONC’s continuing efforts to move the nation’s healthcare system toward improved patient care," they added.

"We expect ONC to hold developers to high standards and implementation timelines, and we also hope that the agency will work with the development community to finalize requirements that are achievable."